MAPT Haploid H1b and the Damage of BBB in Dorsal Medulla Oblongata and Autonomic Dysfunction in PD

NCT ID: NCT05471713

Last Updated: 2022-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-30

Brief Summary

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This study mainly explored the relationship between the permeability of the blood-brain barrier in the dorsal medulla oblongata and autonomic dysfunction, and the relationship and mechanism of MAPT genotype on the permeability of the blood-brain barrier and the progression of autonomic dysfunction in PD patients.

Detailed Description

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According to the MDS 2015 clinical diagnostic criteria for Parkinson's disease and the diagnostic criteria for autonomic dysfunction (AutD), the patients were divided into PD with AutD group and PD without AutD group. DCE results, pet-pdrp+18f-dopa data and clinical evaluation (SCOPA-AUT, HRV and sleep EEG) were analyzed; Blood samples were collected to detect MAPT gene polymorphism, oligomers and phosphorylated synuclein. To explore the relationship between the permeability of the blood-brain barrier in the dorsal medulla oblongata and autonomic dysfunction, and the relationship and mechanism of MAPT genotype on the permeability of the blood-brain barrier and the progression of autonomic dysfunction in PD patients.

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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PD with AutD

Parkinson's disease with autonomic dysfunction

Autonomic dysfunction

Intervention Type OTHER

Autonomic dysfunction

PD without AutD

Parkinson's disease without autonomic dysfunction

No interventions assigned to this group

Interventions

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Autonomic dysfunction

Autonomic dysfunction

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Meet the diagnostic criteria for idiopathic PD of MDS 2015
* Age ≥ 45 years old
* Be able to complete various clinical evaluations and scales; Willing to participate in MRI, no contrast agent allergy

Exclusion Criteria

* Dementia was diagnosed before or 1 year after the onset of motor symptoms
* Single gene form of PD
* Coexisting neuropathological diagnosis considered to affect PD progression
* Known complications affecting BBB (severe infection, cerebral infarction, etc.
* Such as comorbidities known to affect the autonomic nervous system (e.g., diabetes gangliopathy or neuropathy)
* Disturbance of consciousness, serious cerebral hemorrhage or cerebral thrombosis, serious brain tumor or brain surgery history, serious mental illness or other serious nervous system diseases, which are enough to seriously interfere with the subjects' motor and non motor symptoms
* According to the judgment of the researcher, the researcher is unable to complete the research test according to the requirements of the research scheme.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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shuzhen zhu, doctor

Role: PRINCIPAL_INVESTIGATOR

Southern Medical University, China

Locations

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Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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shuzhen zhu, doctor

Role: CONTACT

86-020-783071

xiaoyan xu

Role: CONTACT

86-13829337718

Facility Contacts

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shuzhen zhu

Role: primary

86-020-783071

Other Identifiers

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2022-KY-034-01

Identifier Type: -

Identifier Source: org_study_id

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